Global Head of Patient Safety Operations

Roche; Basel; Vor Ort; CHF 350.000 - 520.000; Vollzeit

Zusammenfassung

Roche seeks a Global Head of Patient Safety Operations to guide the strategy and execution of patient safety activities across regions. You will lead a diverse team, collaborate with senior stakeholders, and ensure compliant, high-quality safety operations at scale.

The role demands extensive PV experience, strong leadership, and the ability to drive continuous improvement in a complex, global matrix environment. Basel-based role with international travel.

Qualifikationen

• MD/PhD/PharmD or other advanced degree is strongly desired.
• Extensive management experience in pharmaceutical safety and PV operations.
• Deep understanding of safety regulations (FDA/EMA/ICH).
• Proven track record in leading large, cross-functional teams.
• Experience managing business process outsourcing vendors.

Aufgaben

• Lead Patient Safety Operations teams responsible for ICSR processing and reporting, including training.
• Collaborate with IPS Global Head, Regional Heads, and Affiliate Safety Leaders on requirements and opportunities.
• Partner with Roche technology teams and vendors to optimize performance and control costs.
• Ensure up-to-date processes with Global Process Owners for safety operations.
• Provide vigilance expertise to clinical, development and marketing teams on data collection and PV activities.
• Negotiate and establish safety agreements with partners (PVAs/SDEAs).
• Lead Regulatory Reporting Services contributions to global safety documentation.

Kenntnisse

Leadership experience

Pharmacovigilance

Regulatory knowledge

Vendor management

Budget management

Cross-functional collaboration

Change management

Communication skills

Travel willingness

Ausbildung

Advanced degree (MD/PhD/Pharma)

Minimum scientific qualification (MD/PhD/MSc/BSc)

Tools

None

Jobbeschreibung

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

The Position

Who We Are

The Product Development Safety (PDS) organisation delivers patient-centric solutions that build trust and create value for society, leading smarter safety design and decision-making activities throughout the lifecycle. PDS sustains Pharmacovigilance (PV) system compliance and quality, to foster trust and drive efficiency while innovating and improving the capabilities that address the evolving priorities of our enterprise.

The Opportunity

The Global Head of Patient Safety Operations is a pivotal role for the organisation and is leading the building and implementation of the Patient Safety Operations strategy, driving industry leading global and regional operational excellence. You will be accountable for the execution of key safety processes that are essential to meet regulatory requirements, aid scientific analysis and advance the delivery of patient centric safety. In this role you drive and strategically lead priorities for Patient Safety Operations across multiple locations supporting the overall PDS Strategy. You lead and empower the Patient Safety Operations team and ensure efficient, cost effective, high quality and compliant delivery of operational activities, establishing beneficial relationships with vendors supporting the Patient Safety Operations deliverables.

Primary Responsibilities And Accountabilities

• Leading Patient Safety Operations Teams responsible for Individual Case Safety reports (ICSR) and medical device safety report collection, processing, and reporting, including associated quality and training activities
• Collaborating closely with stakeholders including International Patient Safety (IPS) Global Head and Regional Heads, Affiliate Safety Leaders to ensure operational requirements, and identification of further opportunities and innovation
• Collaborating closely with Roche technology organisations and technology vendors to maximize technological performance while driving cost optimization
• Working closely with the Global Process Owners and Business Process Owners to ensure up-to-date processes and procedures
• Providing vigilance expertise on operational processes to stakeholders including clinical, development and marketing teams. Consulting on safety data collection obligations from all sources of Roche Pharma products and modalities, classification and assessment of global digital activities, review of eCRFs for clinical trials, PV approval for global Market Research and Patient Support Programs
• Negotiating, implementing and establishing safety agreements (eg. PVAs, SDEAs, Safety Management Plans etc) with partners
• Leading and guiding Regulatory Reporting Services Team accountable for contributing information to the global Safety Regulatory Document Preparation process

PDS performance standards within Patient Safety Operations moving towards quality and compliance as a competitive advantage:

• Ensuring tasks are performed according to international regulatory requirements, internal standards and in alignment with PDS strategies
• Achieving defined performance metrics for patient safety operations processes
• Ensuring Patient Safety Operations function is inspection ready, assisting PDS and Pharma Development (PD) Quality during inspections and audits
• Partnering with PD and Pharma stakeholders to set clear data standards for provision of information, facilitating high quality compliant safety data processing

Continuous improvement activities in pharmacovigilance, particularly in relation to safety operations processes:

• Identifying necessary changes to policy, process or organisation to improve compliance, quality and efficiency, proposing changes to the Global Process Owner and/or PDS Leadership Team and/or Good Vigilance Practice Council, and driving implementation of agreed change
• Establishing and implementing best practice sharing in pharmacovigilance activities and identifying and implementing continuous improvement activities in support of operational PV
• In collaboration with PDS vendor management responsibles, developing and implementing operational sourcing strategies to optimize cost, capacity, quality, and performance by finding the right balance between internal and external resources
• Continually assessing the Patient Safety Operations capability needs to ensure readiness for future requirements

Leading and managing Patient Safety Operations team:

• Leading and inspiring the Patient Safety Operations organisation, indirect leadership to vendors supporting Patient Safety Operations across multiple locations and cultures
• Role modeling as a leader and strongly influencing others beyond reporting lines to deliver meaningful outcomes and maximum impact
• Member of the PDS Leadership Team, contributing to the overall management of the PDS department
• Identifying future talent needs and attracting talent. Ensuring that team members are coached, trained and developed to maximize impact and the well-being of the team
• Leading effective change management across Patient Safety Operations in support of the Safety Strategy
• Having budget accountability for Patient Safety Operations

Effective running of PD Safety Risk Management:

• Building and sustaining strong trustful relationships with Global Head Safety Risk Management, peers and other key stakeholders
• Collaborating closely with Global Head International Patient Safety to ensure the operational requirements of Affiliate Patient Safety are met
• Understanding deeply the key value drivers of a leading global Safety Risk Management function
• Ability for a strong critical thinking, creating and shaping meaningful, deliverable actions
• Anticipating potential issues, risks, opportunities, and actions to prioritise and focus, helping others do the same

Who You Are:

• MD, PharmD, PhD, or other advanced degree strongly desired
• Minimum scientific qualification: (MD, PhD, MSc or Bachelor’s Degree) in health care profession or relevant life science or nature science discipline
• Extensive and many years of management experience in pharmaceutical safety, including a thorough understanding of safety operations and regulatory requirements, with a broad understanding of downstream activities (e.g. signal detection, evaluation and risk management processes), proven familiarity with global health authority Pharmacovigilance standards (eg FDA, EMA) and ICH regulations and guidelines
• Demonstrated success in leading large teams, changing culture and delivering impact whilst managing budget and timelines
• Proven track record in managing business process outsourcing vendors and relationships
• Strong ability in successfully driving complex, cross functional projects and process improvements in a complex, global matrix environment
• Deep sense for continuous improvement and excellence applying a sound strategic thinking capability
• Profound relationship building skills, with ability to interact effectively in a multifunctional and multicultural team setting
• Strong change management experiences and leading transformation
• Excellent written and verbal communication across all levels with demonstrated influencing and negotiation skills
• Ability to operate objectively and independently as a leader and as a member of a team, as required
• Willingness to travel internationally and work across cultures

Where pay transparency applies, details are provided based on the primary posting location. For this role, the primary location is Basel. If you are interested in additional locations where the role may be available, we will provide the relevant compensation details later in the hiring process.

Who we are

A healthier future drives us to innovate. Together, more than 100'000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Lets build a healthier future, together.

Roche is an Equal Opportunity Employer.